Summary of Job Responsibilities:
• Reads and understands the Clinical Study Protocols, Cytel Work Request Documents, and Project Requirements.
• Prepares and reviews Pharmacokinetic Analysis Plan (PKAP) using Clinical Study Protocols and Study Specifications.
• Performs Integral data management, data cleaning process, and integration with Phoenix WinNonlin® software.
• PK/PD analysis using Phoenix WinNonlin® 8.1 or higher software, in accordance with study specifications.
• Plays an active role in planning, execution and delivery of pharmacokinetic assignments ensuring on-time quality deliveries.
• Creates Tables, Listings, and Figures (TLFs), and summary reports for regulatory submission.
• Interprets PK results and prepares pharmacokinetic content for Clinical Study Reports (CSRs).
• Perform quality control and quality assurance of PK deliverables as per the client assignment specifications.
• Provide strategic leadership to a team in conducting clinical pharmacokinetic studies, ensuring timely execution and adherence to guidelines.
• Should be proactive to pursue advanced technological aspects and mentor the team members in various technical and strategic aspects to meet the organization objectives.
• Acts as the primary client interface for technical support and project coordination, attending meetings to capture evolving requirements, track commitments, and ensure timely delivery.
• Should closely work with the higher management and business team for the effective project management
• Co-ordinates cross-functional activities involving statisticians, SAS® programmers and medical writers involved in pharmacokinetic projects.
• Co-ordinates with the client and US-team for clarity of specifications, data issues, reviews, schedules, etc.
• Reads and thoroughly understands applicable compliance standards such as GCP, 21CFR11, ISO 17799 and client’s SOPs.
Minimum Education:
Master of Pharmacy (M. Pharmacy) / in Pharmacology/Pharmaceutics/Pharmaceutical technology
Minimum Work Requirements:
8-10 years of hands-on experience in PK/PD analysis, interpretation and reporting of clinical trials data using Phoenix WinNonlin® software.
Should have profound knowledge in biopharmaceutics, pharmacology, clinical research, pharmacokinetics and pharmacodynamic (PK/PD) concepts.
Should be proficient in the concepts of Clinical Trials, Good Clinical Practices (GCP), SOPs and regulatory specifications.
Should have good academic credits and excellent communication skills (oral and written).
Skills:
Expertise in Phoenix WinNonlin® software in creating workflows independently.
Demonstrated strong understanding of Drug Discovery and Development, PK/PD principles, physiology/pharmacology and biopharmaceutics through scientific presentations, posters, and publications.
Proficiency in Medical and Scientific writing.
Knowledge in using GraphPad Prism, R Programming and SAS® software.
Thorough knowledge regarding International Conference on Harmonization-Good Clinical Practice. Basic Knowledge regarding Clinical Trials Methodologies
